ibuprofen + paracetamol




Full Prescribing Info
Ibuprofen, paracetamol.
Each film-coated tablet contains Ibuprofen BP 400 mg, Paracetamol BP 325 mg.
Ibuprofen is a non-steroidal anti-inflammatory agent with molecular formula of C13H18O2. Its molecular weight is 206.3.
Paracetamol, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic. Its molecular weight is 151.2 with molecular formula of C8H9NO2.
Pharmacology: Mechanism of action: Ibuprofen has prominent anti-inflammatory effects in addition to having analgesic and antipyretic actions. The analgesic effects of ibuprofen are due to both peripheral and a central effect, and are distinct from its property as an anti-inflammatory drug. Ibuprofen is a potent inhibitor of the enzyme cyclo-oxygenase which thus results in a marked reduction of prostaglandin synthesis.
Paracetamol may act predominantly by inhibiting prostaglandin synthesis in the central nervous system (CNS) and, to a lesser extent, through a peripheral action by blocking pain-impulse generation. The peripheral action may be due to inhibition of prostaglandin synthesis or to inhibition of the synthesis or actions of other substances that sensitize pain receptors to mechanical or chemical stimulation. Paracetamol probably produces anti-pyresis by acting centrally on the hypothalamus heat-regulating center to produce peripheral vasodilatation resulting in increased blood flow through the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus.
Some 2 to 5% of a therapeutic dose of paracetamol is excreted unchanged in the urine. Its renal clearance is about 10 ml/min and is weakly dependent on urine flow rate but not on pH.
Pharmacokinetics: Pharmacokinetics of Ibuprofen and Paracetamol when given in combination: Ibuprofen and paracetamol do not seem to affect each other's pharmacokinetics when taken concurrently. This has been established in a study where ibuprofen and paracetamol were given concurrently to 20 healthy volunteers in a randomized crossover design.
Pharmacokinetics in Special Populations: Ibuprofen: Elderly: Old age has no effect on the elimination of ibuprofen.
Renal Impairment: Impairment has no effect on the kinetics of the drug, rapid metabolism still occurs as a consequence of metabolism.
Paracetamol: Renal Impairment: The kinetics of paracetamol elimination has been investigated in patients with renal diseases. No significant changes were observed.
Hepatic Impairment: The kinetics of paracetamol elimination has been investigated in patients with hepatic diseases. No significant changes were observed except in the patients with severe acute and decompensated chronic liver disease in whom the half-life was considerably prolonged.
Toxicology: Carcinogenicity/Mutagenicity/Impairment of Fertility: No evidence of carcinogenicity has been seen in rats. Reproduction studies on white rabbits in the early part of pregnancy showed no treatment related abnormalities; similar satisfactory results were obtained with mice and rats.
Paracetamol demonstrated no carcinogenic potential in F344 rats of either sex. No pathologic or statistical evidence of induction of tumors by acetaminophen was found.
Paracetamol inhibits both replicative DNA synthesis and DNA repair synthesis in vitro and in experimental animals. Paracetamol does not cause gene mutation, either in bacteria or in mammalian cells. A co-mutagenic effect of Paracetamol has however been reported. Furthermore, Paracetamol increases the frequency of chromosomal damage in mammalian cell lines, isolated human lymphocytes and experimental animals.
Chronic toxicity studies in animals have shown that high doses of paracetamol cause testicular atrophy and inhibition of spermatogenesis.
BRUSTAN tablets are indicated for the relief of mild to moderate pain associated with inflammation. BRUSTAN tablets are also used for fever relief e.g. fever from cold or influenza. DO NOT USE BRUSTAN IN FEVER CAUSED BY DENGUE VIRUS (HEMORRHAGIC FEVER).
Dosage/Direction for Use
Not recommended for children under twelve years.
Adults: One to two tablets three times a day. Tablets are to be taken with food or after meals with sufficient water. Not more than six tablets must be taken daily.
Ibuprofen: Approximately 1½ hours after the reported ingestion of from 7 to 10 Ibuprofen Tablets (400mg), a 19-month old child weighing 12 kg was seen in the hospital emergency room, apneic and cyanotic, responding only to painful stimuli. This type of stimulus, however, was sufficient to induce respiration. Oxygen and parenteral fluids were given; a greenish-yellow fluid was aspirated from the stomach with no evidence to indicate the presence of ibuprofen. Two hours after ingestion the child's condition seemed stable; she still responded only to painful stimuli and continued to have periods of apnea lasting from 5 to 10 seconds. She was admitted to intensive care and sodium bicarbonate was administered as well as infusions of dextrose and normal saline. By four hours post-ingestion she could be aroused easily, sit by herself and respond to spoken commands. Blood level of ibuprofen was 102.9 µg/mL, approximately 8½ hours after accidental ingestion. At 12 hours she appeared to be completely recovered.
In two other reported cases where children (each weighing approximately 10 kg) accidentally, acutely ingested approximately 120 mg/kg, there were no signs of acute intoxication or late sequela. Blood level in one child 90 minutes after ingestion was 700 µg/mL about 10 times the peak levels seen in absorption excretion studies.
A 19-year old male who had taken 8,000 mg of ibuprofen over a period of a few hours complained of dizziness, and nystagmus was noted. After hospitalization, parenteral hydration and three days bed rest, he recovered with no reported sequela.
In cases of acute overdosage, the stomach should be emptied by vomiting or lavage, though little drug will likely be recovered if more than an hour has elapsed since ingestion. Because the drug is acidic and is excreted in the urine, it is theoretically beneficial to administer alkali and induce diuresis. In addition to supportive measures, the use of oral activated charcoal may help to reduce the absorption and re-absorption of ibuprofen.
Paracetamol: Symptoms of Paracetamol overdosage in the first twenty-four hours are pallor, nausea, vomiting, anorexia, and abdominal pain. Liver damage may become apparent twelve to forty-eight hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur.
Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias have been reported. Symptoms during the first two days of acute poisoning do not reflect the potential seriousness of the overdosage. Nausea, vomiting, anorexia and abdominal pain may persist for a week or more. Liver injury may become manifest on the second day (or later), initially by elevation of serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration and prolongation of prothrombin time. The liver damage may progress to encephalopathy, coma and death. Cerebral oedema and nonspecific myocardial depression have also occurred.
In the event of overdosage consult a doctor or take the patient to the nearest hospital immediately. Specialized treatment is essential as soon as possible. Prompt treatment is essential. Any patient who has ingested about 7.5 g of Paracetamol in the preceding four hours should undergo gastric lavage. Specific therapy with an antidote such as acetylcysteine or methionine may be necessary. If decided upon, acetylcysteine should be administered IV (intravenously) as soon as possible.
Acetylcysteine: Acetylcysteine should be administered as soon as possible, preferably within eight hours of overdosage.
Orally: 140 mg/kg as a 5% solution initially, followed by a 70 mg/kg solution every four hours for 17 doses. Acetylcysteine is effective if administered within eight hours of overdosage.
IV: An initial dose of 150 mg/kg in 200 mL glucose injection, given intravenously over fifteen minutes, followed by an intravenous infusion of 50 mg/kg in 500 ml of glucose injection over the next four hours, and then 100 mg/kg in 1000 mL over the next sixteen hours. The volume of intravenous fluids should be modified for children.
BRUSTAN tablets are contraindicated in patients with following conditions: 1. Hemorrhagic fever.
2. History of severe allergic reaction such as anaphylaxis or angioedema, induced by aspirin or other NSAIDs. Because of the possibility of cross-sensitivity due to structural relationships which exist among non-steroidal anti-inflammatory medicines, acute allergic reactions are likely to occur in patients who have exhibited allergic reactions to these compounds.
3. Patients sensitive to any of the ingredients.
4. Aspirin induced nasal polyps associated with bronchospasm (High risk of severe allergic reactions because of cross sensitivity).
5. Children under the age of 2 years.
6. Active peptic ulceration.
7. Severe renal function impairment.
8. Safety in pregnancy and lactation has not been established
Risk of GI Ulceration, Bleeding and Perforation with Non-steroidal Anti-inflammatory Therapy: Serious gastrointestinal toxicity such as bleeding, ulceration, and perforation, can occur at any time, with or without warning symptoms, in patients treated chronically with non-steroidal anti-inflammatory drugs. Although minor upper gastrointestinal problems, such as dyspepsia, are common, usually developing early in therapy, physicians should remain alert for ulceration and bleeding in patients treated chronically with non-steroidal anti-inflammatory drugs even in the absence of previous GI tract symptoms. In patients observed in clinical trials of several months to two years duration, symptomatic upper GI ulcers, gross bleeding or perforation appear to occur in approximately 1% of patients treated for 3-6 months, and in about 2-4% of patients treated for one year. Physicians should inform patients about the signs and/or symptoms of serious GI toxicity and what steps to take if they occur.
Dosage in excess of those recommended may cause severe liver function damage. Patients suffering from liver or kidney disease should take Paracetamol under medical supervision.
Consult a doctor if no relief is obtained from the recommended dosage.
Do not use continuously for more than 10 days without consulting a doctor.
Do not take with any other paracetamol-containing products.
Special Precautions
General: Prolonged use of this medication may increase the risk of adverse renal effects. It is recommended that patient should be under close medical supervision while receiving such combined therapy.
Cross-sensitivity and/or related problems: Patients sensitive to one of the NSAIDs may be sensitive to any of the other NSAIDs also. NSAIDs may cause bronchoconstriction or anaphylaxis in aspirin sensitive asthmatics, especially those with aspirin induced nasal polyps, asthma and other allergic reactions (the "aspirin triad").
Dental: NSAIDs may cause soreness, irritation, or ulceration of oral mucosa. Ibuprofen may rarely cause leukopenia and/or thrombocytopenia, which may result in an increased incidence of microbial infection, delayed healing, and gingival bleeding. If leukopenia or thrombocytopenia occurs, dental work should be deferred until blood counts have returned to normal, and patients should be instructed in proper oral hygiene, including caution in use of regular tooth brushes, dental floss and toothpicks.
Surgical: Caution is recommended in patients who require surgery. Most NSAIDs inhibit platelet aggregation and may prolong bleeding time, which may increase intra- and postoperative bleeding. Recovery of platelet function may occur within one day after discontinuation of ibuprofen. Consideration should be given to discontinuing NSAID treatment for an appropriate length of time prior to elective surgery, depending on the potency and duration of effect of the individual agent on platelet aggregability.
Special Precautions: Mild allergic reaction such as allergic rhinitis, urticaria or skin rash induced by aspirin or other NSAIDs; Anemia; Asthma; Conditions such as compromised cardiac function, congestive heart disease, pre-existing edema, renal function impairment; Conditions predisposing to gastro-intestinal toxicity, such as active alcoholism, inflammatory or ulcerative disease of upper or lower gastrointestinal tract, including Crohn's disease, diverticulitis, peptic ulcer disease, or ulcerative colitis and recent history of tobacco use; Hemophilia or other bleeding problems including coagulation or platelet function disorders; Hepatic cirrhosis or hepatic function impairment; Renal function impairment; Stomatitis; Systemic lupus erythematosus; Aseptic meningitis with fever and coma has been observed on rare occasions in patients on ibuprofen therapy.
Information for patients: Ibuprofen, like other drugs of its class, is not free of side effects. The side effects of these drugs can cause discomfort and, rarely, there are more serious side effects, such as gastrointestinal bleeding, which may result in hospitalization and even fatal outcomes.
Physicians may wish to discuss with their patients the potential risks (see PRECAUTIONS and ADVERSE REACTIONS) and likely benefits of non-steroidal anti-inflammatory drug treatment, particularly when the drugs are used for less serious conditions where treatment without such agents may represent an acceptable alternative to both the patient and physician.
Use in Children: BRUSTAN tablets are not recommended for use in children under the age of twelve years.
Use in the Elderly: NSAID-induced gastro-intestinal ulceration and/or bleeding may be more likely to cause serious consequences, including fatalities, in geriatric patients than in younger adults. In addition, elderly patients are more likely to have age-related renal function impairment, which may increase the risk of NSAID-induced hepatic and renal toxicity and may also require dosage reduction to prevent accumulation of the medication. Also, careful monitoring of the patient is recommended.
Use In Pregnancy & Lactation
Ibuprofen: Use in Pregnancy: Reproductive studies conducted in rats and rabbits at doses somewhat less than the maximal clinical dose did not demonstrate evidence of developmental abnormalities. However, animal reproduction studies are not always predictive of human response. As there are no adequate and well-controlled studies in pregnant women, this drug should be used during pregnancy only if clearly needed. Because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system (closure of ducts arteriosus), use during late pregnancy should be avoided. As with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia and delayed parturition occurred in rats. Administration of ibuprofen is not recommended during pregnancy.
Use in Lactation: In limited studies, an assay capable of detecting 1 mcg/mL did not demonstrate ibuprofen in the milk of lactating mothers. However, because of the limited nature of the studies, and the possible adverse effects of prostaglandin-inhibiting drugs on neonates, ibuprofen is not recommended for use in nursing mothers.
Paracetamol: Use in Pregnancy (Category A): Epidemiological studies in human pregnancy have shown no ill effects due to Paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.
Use in Lactation: Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data does not contraindicate breast-feeding.
BRUSTAN tablets are not recommended for use by pregnant or breast-feeding women.
Adverse Reactions
Ibuprofen: The most frequent type of adverse reaction occurring with Ibuprofen Tablets is gastrointestinal. In controlled clinical trials the percentage of patients reporting one or more gastrointestinal complaints ranged from 4% to 16%. In controlled studies when ibuprofen was compared to aspirin and indomethacin in equally effective doses, the overall incidence of gastrointestinal complaints was about half that seen in either the aspirin or indomethacin treated patients.
Adverse reactions observed during controlled clinical trials at an incidence greater than 1% are listed in the following paragraphs. Those reactions listed under the heading, incidence >1% (but less than 3%) Probable Causal Relationship, encompass observations in approximately 3,000 patients. More than 500 of these patients were treated for periods of at least 54 weeks.
Still other reactions occurring less frequently than 1 in 100 were reported in controlled clinical trials and from marketing experience. These reactions have been divided into two categories: Precise Incidence Unknown (but less than 1%) Probable Causal Relationship lists reactions with therapy with ibuprofen where the probability of a causal relationship exists: Precise Incidence Unknown (but less than 1%) Causal Relationship Unknown lists reactions where a causal relationship with ibuprofen has not been established.
Reported side effects were higher at doses of 3200 mg/day than at doses of 2400 mg or less per day in clinical trials of patients with rheumatoid arthritis. The increases in incidence were slight and still within the ranges reported in the following paragraphs.
Incidences greater than 1% (but less than 3%) Probable Causal Relationship: Gastrointestinal: nausea*, epigastric pain*, heartburn*, diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or pain, fullness of GI tract (bloating and flatulence).
Central Nervous System: dizziness*, headache, nervousness.
Dermatologic: rash* (including maculopapular type), pruritus.
Special Senses: tinnitus.
Metabolic/Endocrine: decreased appetite.
Cardiovascular: edema, fluid retention (generally responds promptly to drug discontinuation) (see PRECAUTIONS).
Precise Incidence Unknown (but less than 1%) Probable Causal Relationship**: Gastrointestinal: gastric or duodenal ulcer with bleeding and/or perforation, gastrointestinal hemorrhage, melena, gastritis, hepatitis, jaundice, abnormal liver function tests, pancreatitis.
Central Nervous System: depression, insomnia, confusion, emotional lability, somnolence, aseptic meningitis with fever and coma (see PRECAUTIONS).
Dermatologic: vesiculobullous eruptions, urticaria, erythema multiforme, Stevens-Johnson syndrome, alopecia.
Special Senses: hearing loss, amblyopia (blurred and/or diminished vision, scotomata and/or changes in color vision) (see PRECAUTIONS).
Hematologic: neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia (sometimes Coombs positive), thrombocytopenia with or without purpura, eosinophilia, decrease in hemoglobin and hematocrit (see PRECAUTIONS).
Cardiovascular: congestive heart failure in patients with marginal cardiac function, elevated blood pressure, palpitations.
Allergic: syndrome of abdominal pain, fever, chills, nausea and vomiting, anaphylaxis, bronchospasm (see Contraindications).
Renal: acute renal failure (see PRECAUTIONS), decreased creatinine clearance, polyuria, azotemia, cystitis, hematuria.
Miscellaneous: dry eyes and mouth, gingival ulcer, rhinitis.
Precise Incidence Unknown (but less than 1%) Causal Relationship Unknown**: Central Nervous System: paresthesias, hallucinations, dream abnormalities, pseudotumor cerebri.
Dermatologic: toxic epidermal necrolysis, photoallergic skin reactions.
Special Senses: conjunctivitis, diplopia, optic neuritis, cataracts.
Hematologic: bleeding episodes (e.g., epistaxis, menorrhagia).
Metabolic/Endocrine: gynecomastia, hypoglycemic reaction, acidosis.
Cardiovascular: arrhythmias (sinus tachycardia, sinus bradycardia).
Allergic: serum sickness, lupus erythematosus syndrome, Henoch-Schonlein vasculitis, angioedema.
Renal: renal papillary necrosis.
* Reactions occurring in 3% to 9% of patients treated with ibuprofen. (Those reactions occurring in less than 3% of the patients are unmarked.)
** Reactions are classified under "Probable Causal Relationship (PCR)" if there has been one positive rechallenge or if three or more cases occur which might be causally related. Reactions are classified under "Causal Relationship Unknown" if seven of more events have been reported but the criteria for PCR have not been met.
Paracetamol: Gastrointestinal System: Nausea, vomiting, stomach pain or cramps, diarrhoea, loss of appetite, hepatotoxicity, hepatic failure, hepatic encephalopathy, gastro-intestinal tract bleeding, pancreatitis.
Central Nervous System: Convulsions, respiratory depression, cerebral oedema, coma.
Haematological: Leucopenia, thrombocytopenia, neutropenia, pancytopenia, agranulocytosis, disseminated intravascular coagulation.
Metabolic: Hypoglycaemia, metabolic acidosis.
Cardiovascular System: Cardiac arrhythmias, cardiovascular collapse.
Renal System: Renal tubular necrosis, renal failure.
Dermatological: Skin rashes and other allergic reactions. The rash is usually erythematous or urticarial but sometimes more serious and may be accompanied by fever and mucosal lesions.
Drug Interactions
Ibuprofen: Coumarin-type anticoagulants: Several short-term controlled studies failed to show that ibuprofen significantly affected prothrombin times or a variety of other clotting factors when administered to individuals on coumarin-type anticoagulants. However, because bleeding has been reported when ibuprofen and other non-steroidal anti-inflammatory agents have been administered to patients on coumarin-type anticoagulants, the physician should be cautious when administering ibuprofen to patients on anticoagulants.
Warfarin: Concurrent use of NSAIDs and warfarin has been associated with severe sometimes fatal haemorrhage. The mechanism of this interaction is not known but may involve increased bleeding from NSAID-induced gastrointestinal ulceration or an additive effect of NSAID inhibition of platelet function with the anticoagulant effect of warfarin.
Ibuprofen should only be used in patients taking warfarin if absolutely necessary. Patients taking this combination must be closely monitored.
Aspirin: Animal studies show that aspirin given with non-steroidal anti-inflammatory agents, including ibuprofen, yields a net decrease in anti-inflammatory activity with lowered blood levels of the non-aspirin drug. Single dose bioavailability studies in normal volunteers have failed to show an effect of aspirin on ibuprofen blood levels. Correlative clinical studies have not been done.
Methotrexate: NSAIDs inhibit tubular secretion of methotrexate in animals. As a result, reduction of clearance of methotrexate may occur. Use of high doses of methotrexate concomitant with NSAIDs should be avoided. At low doses of methotrexate caution should be used if ibuprofen is administered concomitantly.
H-2 Antagonists: In studies with human volunteers, co administration of cimetidine or ranitidine with ibuprofen had no substantive effect on ibuprofen serum concentrations.
Diuretics: Clinical studies, as well as random observations, have shown that ibuprofen can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with ibuprofen, the patient should be observed closely for signs of renal failure (see PRECAUTIONS), as well as to assure diuretic efficacy.
Lithium: Ibuprofen produced an elevation of plasma lithium levels and a reduction in renal lithium clearance in a study of eleven normal volunteers. The mean minimum lithium concentration increased 15% and the renal clearance of lithium was decreased by 19% during this period of concomitant drug administration. This effect has been attributed to inhibition of renal prostaglandin synthesis by ibuprofen. Thus, when ibuprofen and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity. (Read circulars for lithium preparation before use of such concurrent therapy.)
Antihypertensive: Ibuprofen like other NSAIDs can reduce the antihypertensive effect of ACE inhibitors and beta-blockers with possible loss of blood pressure control and can attenuate the natriuretic effects of thiazide diuretics and furosemide.
Glycosides: NSAIDs may increase plasma cardiac glycoside levels. Care should therefore be taken in patients treated with cardiac glycosides.
Alcohol or corticosteroids or chronic therapeutic use of corticotrophin or potassium supplements: Concurrent use with ibuprofen may increase the risk of gastrointestinal side effects, including ulceration or haemorrhage.
Oral antidiabetic agents or insulin: Ibuprofen may increase the hypoglycemic effect of these medications because prostaglandins are directly involved in regulatory mechanisms of glucose metabolism and possibly because of displacement of the oral anti-diabetics from serum proteins. Hence, dosage adjustments of anti-diabetic agent may be necessary.
Bone marrow depressants: Leukopenic and/or thrombocytopenic effects of these medications may be increased with concurrent or recent therapy; dosage adjustment of the bone marrow depressant, if necessary, should be based on blood counts.
Cefamandole or cefoperazone or cefotetan or plicamycin or valproic acid: These medications may cause hypoprothrombinemia; in addition, plicamycin or valproic acid may inhibit platelet aggregation; concurrent use with ibuprofen may increase the risk of bleeding because of additive interferences with platelet function and/or the potential occurrence of ibuprofen-induced gastro-intestinal ulceration or hemorrhage.
Cyclosporine or gold compounds and other nephrotoxic compounds: Inhibition of renal prostaglandin activity by ibuprofen may increase the plasma concentration of cyclosporine and/or the risk of cyclosporine induced nephrotoxicity; patients should be carefully monitored during concurrent use.
Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effects of mifepristone.
Laboratory Tests: Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians should follow chronically treated patients for the signs and symptoms of ulcerations and bleeding and should inform them of the importance of this follow-up (see Risk of GI Ulceration, Bleeding and Perforation with Non-steroidal Anti-inflammatory Therapy under WARNINGS).
Paracetamol: Alcohol and Hepatic Enzyme Inducers: Risk of hepatotoxicity with single toxic dose or prolonged use of high dose of Paracetamol may be increased in alcoholics or in patients regularly taking other hepatotoxic medications or hepatic enzyme inducers.
Barbiturates and Antidepressants: Concomitant barbiturates and tricyclic antidepressants may increase the hepatotoxicity of Paracetamol particularly after overdose. Chronic use of barbiturates (except Butalbital) or primidone has been reported to decrease the therapeutic effects of acetaminophen, probably because of increased metabolism resulting from induction of hepatic microsomal enzyme activity; the possibility should be considered that similar effects may occur with other hepatic enzyme inducers.
Anti-convulsant: Anti-convulsant or oral steroid contraceptives have the ability to reduce serum levels of Paracetamol by liver enzyme induction.
Metoclopramide: The rate absorption of Paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.
Anti-inflammatory drugs (NSAIDs): Prolonged concurrent use of acetaminophen and a salicylate is not recommended because recent evidence suggests that chronic high-dose administration of the combined analgesics significantly increases the risk of analgesic nephropathy, renal papillary necrosis, end stage renal disease and cancer of the kidney or urinary bladder, also, it is recommended that for short-term use, the combined dose of acetaminophen plus salicylate given alone.
Prolonged concurrent use of acetaminophen and NSAID other than aspirin may also increase the risk of adverse renal effects; it is recommended that patients be under close medical supervision while receiving such combined therapy.
Anti-coagulants, coumarin or indandione derivatives: Concurrent chronic, high dose administration of acetaminophen may increase the anticoagulant effect, possible by decreasing hepatic synthesis of procoagulant factors; anticoagulant dosage adjustment based on increased monitoring of prothrombin time may be necessary when chronic; high dose acetaminophen therapy is initiated or discontinued; however, this does not apply to occasional use, or to chronic use of doses below 2 grams per day, of acetaminophen.
Cholestyramine: The absorption of Paracetamol is reduced by cholestyramine. Therefore, the cholestyramine should not be taken within one hour if maximal is analgesia.
Chloramphenicol: Increased plasma concentration of chloramphenicol has been reported.
Do not store above 30°C, protect from moisture.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
N02BE51 - paracetamol, combinations excl. psycholeptics ; Belongs to the class of anilide preparations. Used to relieve pain and fever.
Brustan tab
10 × 10's;50 × 10's
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